DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1 and 4-13 are pending in this application. Claims 1 and 4 are under examination herein. Claims 5-13 are withdrawn from consideration.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al (WO 2014/125444 A1 – previously cited).
Regarding claim 1, Bandyopadhyay teaches the compounds of Formula II below (page 17) as an RIPK1 inhibitor for the treatment of cancer – which is the same intended use as the instant compounds (page 1, para. 1-2). Bandyopadhyay’s compounds render the instant compounds obvious when X is O; R5 is C1 alkyl; L is -CH2-; B is phenyl substituted with halogen; the 5-membered heterocycle A1-5 form a pyrazolyl; Z1-2, 4 are CH; Z3 is CR3, wherein R3 can be, in preferred embodiments, tetrahydrofuran-2-yl-CH2-O-, pyrrolidine-1-yl-(CH2)2-O-, or morpholin-4-yl-C(O)-, etc (page 15, bottom of page).
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Bandyopadhyay specifically discloses the preferred embodiments 31, 32, and 93 below (pages 142 and 154).
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While embodiments 31 and 32 don’t show F substitution of the phenyl corresponding to ring B; or pyrazole in the position corresponding to the 5-member ring A1-5, embodiment 125 and the general Formula II above accounts for these differences. Thus, Bandyopadhyay’s disclosure encompasses a broad genus which encompasses at least the instantly claimed compounds below:
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by the disclosed formula and preferred embodiments; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Bandyopadhyay. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Applicant is advised that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Furthermore, a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Regarding claim 4, Bandyopadhyay discloses a pharmaceutical composition comprising their compounds and acceptable excipients (reading on carriers) (page 50, lines 11-15).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 12,365,695 (US ‘695) (previously Copending Application 16/987,906); in view of Bandyopadhyay et al. (WO 2014/125444 A1 – previously cited).
Regarding claims 1 and 4, US ‘695 claims the compound below, also as an RIPK1 inhibitor – which is the same use as the instant compounds and pharmaceutical compositions thereof (US ‘695’s claims 1 and 7).
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While US ‘695 does not specifically disclose heterocyclic substituents in the place corresponding to methoxy; the teachings of Bandyopadhyay are relied upon for these disclosures.
Bandyopadhyay teaches the compounds of Formula II below (page 17) as an RIPK1 inhibitor for the treatment of cancer – which is the same intended use as the instant compounds (page 1, para. 1-2). Bandyopadhyay’s compounds render the instant compounds obvious when X is O; R5 is C1 alkyl; L is -CH2-; B is phenyl substituted with halogen; the 5-membered heterocycle A1-5 form a pyrazolyl; Z1-2, 4 are CH; Z3 is CR3, wherein R3 can be, in preferred embodiments, tetrahydrofuran-2-yl-CH2-O-, pyrrolidine-1-yl-(CH2)2-O-, or morpholin-4-yl-C(O)-, etc (page 15, bottom of page).
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Bandyopadhyay specifically discloses the preferred embodiments 31, 32, and 93 below (pages 142 and 154).
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While embodiments 31 and 32 don’t show F substitution of the phenyl corresponding to ring B; or pyrazole in the position corresponding to the 5-member ring A1-5, embodiment 125 and the general Formula II above accounts for these differences. Thus, Bandyopadhyay’s disclosure encompasses a broad genus which encompasses at least the instantly claimed compounds below:
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by the US ‘695’s compounds in view of Bandyopadhyay’s generic formula and prefered embodiments. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by US ‘695 in view of Bandyopadhyay. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Furthermore, a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Response to Arguments
Claims
Claim amendments are acknowledged. No new matter has been introduced.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive.
Applicant states, since their elected compound was allegedly allowable, then all the compounds of their amended claim 1 are allowable. This is not the case for the reasons outlined in this final office action. In particular, Bandyopadhyay’s disclosure renders some of the claimed compounds obvious, and thus, not patentable.
Double Patenting
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive.
Applicant argues, since rejections are provisional, that provisional non-statutory double patenting (NSDP) rejections be held in abeyance until the application is in condition of allowance.
This is not persuasive. Previously copending Application 16/987,906 had been mailed a notice of allowance at the time the non-final action was mailed on 05/22/2025. This application has since been patented as US Pat. No. 12,365,695 (US ‘695). Therefore, the NSDP rejection is no longer provisional. Claims stand rejected over obviousness-type NSDP over US Pat. No. 12,365,695 (US ‘695).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613